Localized Pancreatic AdenocarcinomaPhase 1/2PREOPANC-5NCT06384560
Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)
A Phase 1/2 study testing Pembrolizumab, Folfirinox and SABR in people with Localized Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
Trial summary
Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
- What is being tested?
- Pembrolizumab, Folfirinox and SABR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesNetherlands
- Study dates
- 23 Sep 2024to Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)
- Male or female participants who are at least 18 years of age on the day of signing informed consent
- Primary resectable or borderline resectable disease (DPCG criteria)
- ECOG performance status 0 or 1
- Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy
- Leucocytes (WBC) ≥ 3.0 X 10*9/l, Platelets ≥ 100X 10*9 /l, Hemoglobin ≥ 6 mmol/l, Renal function: E-GFR > 50 ml/min, Bilirubin < 50 µmol/l or planned for biliary drainage
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- A male participant must agree to use a contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least one of the following conditions applies: Not a:
- woman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 18 weeks after the last dose of study treatment Written informed consent
Who cannot join
- Metastatic or locally advanced (i.e. unresectable) pancreatic cancer.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
- Complete dihydropyrimidine dehydrogenase deficiency. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid re placement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection.
- Has had an allogenic tissue/solid organ transplant.
- Serious concomitant systemic disorders that would compromise the safety of the patient or their ability to complete the study, at the discretion of the investigator.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to start of treatment (see Appendix 6). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit until 18 weeks after the last dose of trial treatment.
- Has contra-indications for MRI (only for Amsterdam UMC and RAKU)
- Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants.
- Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal.
- Patients with severe claustrophobia not able to tolerate an MRI scan
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
A. M. Gehrels, MD, MA contact
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Prof. dr. J.W. Wilmink, +310204444321, j.w.wilmink@amsterdamumc.nl
- Not yet recruiting
Maastricht University Medical Center
Maastricht
Dr. J. de Vos-Geelen, +310433876543, judith.de.vos@mumc.nl
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
Dr. M. Los, +310883203000, m.los@antoniusziekenhuis.nl
- Recruiting
Erasmus University Medical Center
Rotterdam
Dr. M. Homs, +310107040704, m.homs@erasmusmc.nl
About this study
Official title: Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib/II Trial of the Dutch Pancreatic Cancer Group
Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.
- Conditions
- Localized Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
- Being tested
- Pembrolizumab, Folfirinox, SABR
- Keywords
- neoadjuvant treatment, checkpoint inhibition, chemotherapy, stereotactic radiotherapy, surgical resection, progression free survival, resectable pancreatic cancer, localized pancreatic cancer, borderline resectable pancreatic cancer, FOLFIRINOX, pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks.
FolfirinoxDrug
FOLFIRINOX is a combination of systemic chemotherapy agents. FOLFIRINOX consists of oxaliplatin at a dose of 85 mg/m2, given as a 2-hour intravenous infusion, immediately followed by leucovorin at a dose of 400 mg/m2 given as a 2-hour intravenous infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute intravenous infusion through a Y-connector. This treatment is followed by a continuous intravenous infusion of 2400 mg/m2 5-FU over a 46-hour period every 2 weeks. (The FOLFIRINOX given in the trial is the modified scheme, whereby the fluorouracil bolus at a dose of 400 mg/m2 is omitted and the irinotecan dose reduced to 150 mg/m2).
SABRRadiation
SABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on five non-consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant FOLFIRINOX, SABR and pembrolizumab | Experimental | Treatment starts with four cycles of neoadjuvant modified FOLFIRINOX chemotherapy every two weeks, combined with pembrolizumab every six weeks, starting at the same day as the second cycle of mFOLFIRINOX. Restaging is performed after cycle 4 of mFOLFIRINOX with a CT-scan and tumor markers. Patients with a response or stable disease will undergo stereotactic radiotherapy 5 X 8 Gy followed by four additional cycles of mFOLFIRNOX and pembrolizumab every six weeks. Restaging is repeated after 8 cycles. Patients undergo surgical exploration, 3-6 weeks after completion of chemotherapy, if they have non-metastatic (borderline) resectable disease on CT-scan of the chest and abdomen. Patients also proceed to surgical exploration if they discontinue neoadjuvant mFOLFIRINOX and/or pembrolizumab because of toxicity or have locoregional progression at restaging. After surgery patients will start within 12 weeks with adjuvant 4 cycles of mFOLFIRINOX and 5 cycles of pembrolizumab every 6 weeks. Receives: Drug: Pembrolizumab; Drug: Folfirinox; Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival rate
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start23 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Erasmus Medical Center, St. Antonius Hospital
- Responsible party
- Principal investigator, Trial Office Medical Oncology VUmc, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384560
- Sponsor's protocol ID
- 2023-508707-20-00
- Other IDs
- 2023
- Acronym
- PREOPANC-5
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib/II Trial of the Dutch Pancreatic Cancer Group
- ClinicalTrials.gov ID
- NCT06384560
- Acronym / sponsor ID
- PREOPANC-5 / 2023-508707-20-00
- Conditions
- Localized Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
- Keywords
- neoadjuvant treatment, checkpoint inhibition, chemotherapy, stereotactic radiotherapy, surgical resection, progression free survival, resectable pancreatic cancer, localized pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Erasmus Medical Center, St. Antonius Hospital
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant FOLFIRINOX, SABR and pembrolizumab | Experimental | Drug: Pembrolizumab, Drug: Folfirinox, Radiation: SABRTreatment starts with four cycles of neoadjuvant modified FOLFIRINOX chemotherapy every two weeks, combined with pembrolizumab every six weeks, starting at the same day as the second cycle of mFOLFIRINOX. Restaging is performed after cycle 4 of mFOLFIRINOX with a CT-scan and tumor markers. Patients with a response or stable disease will undergo stereotactic radiotherapy 5 X 8 Gy followed by four additional cycles of mFOLFIRNOX and pembrolizumab every six weeks. Restaging is repeated after 8 cycles. Patients undergo surgical exploration, 3-6 weeks after completion of chemotherapy, if they have non-metastatic (borderline) resectable disease on CT-scan of the chest and abdomen. Patients also proceed to surgical exploration if they discontinue neoadjuvant mFOLFIRINOX and/or pembrolizumab because of toxicity or have locoregional progression at restaging. After surgery patients will start within 12 weeks with adjuvant 4 cycles of mFOLFIRINOX and 5 cycles of pembrolizumab every 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)
- Male or female participants who are at least 18 years of age on the day of signing informed consent
- Primary resectable or borderline resectable disease (DPCG criteria)
- ECOG performance status 0 or 1
- Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy
Key exclusion criteria (23 listed)
- Metastatic or locally advanced (i.e. unresectable) pancreatic cancer.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks. | Drug | Neoadjuvant FOLFIRINOX, SABR and pembrolizumab |
| FolfirinoxFOLFIRINOX is a combination of systemic chemotherapy agents. FOLFIRINOX consists of oxaliplatin at a dose of 85 mg/m2, given as a 2-hour intravenous infusion, immediately followed by leucovorin at a dose of 400 mg/m2 given as a 2-hour intravenous infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute intravenous infusion through a Y-connector. This treatment is followed by a continuous intravenous infusion of 2400 mg/m2 5-FU over a 46-hour period every 2 weeks. (The FOLFIRINOX given in the trial is the modified scheme, whereby the fluorouracil bolus at a dose of 400 mg/m2 is omitted and the irinotecan dose reduced to 150 mg/m2). | Drug | Neoadjuvant FOLFIRINOX, SABR and pembrolizumab |
| SABRSABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on five non-consecutive days. | Radiation | Neoadjuvant FOLFIRINOX, SABR and pembrolizumab |
Primary outcome
1-year progression-free survival rate
Time frame: 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A. M. Gehrels, MD, MA contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab, Folfirinox and SABR in people with Localized Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. W. Wilmink, MD, PhD (+31 204444321, j.w.wilmink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival rate (time frame: 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.